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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE U-DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE U-DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400100000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/26/2018
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer field service technician reported that the device was overheating during testing at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
The reported event of heat was not duplicated during the functional evaluation.Upon disassembly, the service technician observed widespread internal corrosion.Based on a review of previous similar events, corrosion may cause or contribute to heat.
 
Event or Problem Description
The manufacturer field service technician reported that the device was overheating during testing at the user facility.There were no adverse consequences related to this event.
 
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Brand Name
CORE U-DRILL
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8096206
Report Number0001811755-2018-02536
Device Sequence Number1903001
Product Code ERL
UDI-Device Identifier04546540401984
UDI-Public04546540401984
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Catalogue Number5400100000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2018
Initial Date Received by Manufacturer 10/26/2018
Supplement Date Received by Manufacturer04/16/2019
Initial Report FDA Received Date11/21/2018
Supplement Report FDA Received Date04/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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